Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes Mellitus.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 2
- 主要终点
- VO2 max
研究概览
简要总结
testing of autonomic function and relationship with exercise and Qol in diabetic patients and controls
详细描述
Cardiovascular autonomic neuropathy is a common (sub)clinical symptom in persons with type 1 diabetes mellitus. Subjects in this non-commercial, monocentric, interventional study undergo autonomic function tests, a maximal ergospirometry and three questionnaires about the quality of life (EQ-5D-3L), the capacity to do physical activities (IPAQ) and the experience of possible symptoms of autonomic dysfunction in daily life (SCOPA-AUT). In this way the influence of type 1 diabetes mellitus on the quality of life, the exercise capacity and the autonomic function can be studied.
The primary aim of this study investigates the potential correlations between the severity of diabetic cardiovascular autonomic neuropathy (DCAN) and both the quality of life and the exercise capacity. As a secondary aim, the influences of gender, age, number of years since diagnosis of type 1 diabetes mellitus, VO2 max predicted, maximal heart rate during exercise, minimal heart rate in rest, maximal RER (Respiratory exchange ratio) and relevant interaction terms are studied.
In total 52 test subjects with type 1 diabetes mellitus and 27 matched control subjects are selected to participate in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Type 1 diabetes mellitus (only for the group of subjects with diabetes mellitus)
- •At least two years with diagnosis of type 1 diabetes mellitus
- •Subject is in a stable condition
- •No hospitalization for any reason in the past three months
- •18 years or older
- •Being capable of doing physical activities
- •Understand the study design and the informed consent
- •Sign the informed consent
- •No simultaneously participation to another study
- •Being capable of moving to the study center
排除标准
- •Uncontrolled hypertension, atrial fibrillation and other cardiovascular conditions
- •Severe lung disease
- •Muscle deficiency
- •Medication with influence on the autonomic nervous system:
- •Beta blockers
- •Alfa blockers
- •Antidepressants
- •Non-catecholamines
- •(anti) cholinergic medication
研究组 & 干预措施
subjects with Type 1 Diabetes mellitus
Type 1 diabetes patients without cardiovascular disease undergo autonomic function testing
干预措施: autonomic function testing (Diagnostic Test)
Healthy controls
healthy people without known disease undergo autonomic function testing
干预措施: autonomic function testing (Diagnostic Test)
结局指标
主要结局
VO2 max
时间窗: day 1
peak oxygen consumption
次要结局
未报告次要终点
研究者
prof. dr. Paul Dendale
prof. dr.
Hasselt University